Fludrocortisone, Oral

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KEY POINTS

• This medicine is taken by mouth to treat Addison's disease and conditions that cause too much sodium to be lost in the urine. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• You may get infections more easily when you are taking this medicine.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: corticosteroid

Generic and brand names: fludrocortisone, oral

What is this medicine used for?

This medicine is taken by mouth to help control the amount of sodium and fluids in your body. It is used to treat Addison's disease and conditions that cause too much sodium to be lost in the urine.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Diabetes
• Glaucoma, cataracts, or other eye problems
• Heart disease, heart failure, or a heart attack
• High blood pressure
• Liver or kidney disease
• Mental disorders such as schizophrenia
• Myasthenia gravis
• Osteoporosis
• Thyroid problems
• Tuberculosis
• Ulcers or colitis

Also tell your provider if you have recently had any kind of infection or severe injury, or if you are scheduled to have surgery. Your medicine dose may need to be adjusted.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. You may have to reduce your dosage gradually.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Also, drinking alcohol may irritate your stomach. Do not drink alcohol unless your healthcare provider approves.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: unexplained swelling, headache, blurred vision, severe weakness.

What should I watch out for?

You need to have blood tests regularly to check the sodium and potassium levels in your blood. You also need to check your blood pressure and have regular checkups while you are taking this medicine. Keep all appointments.

You may need to follow a low-sodium diet if you have swelling in your legs or feet. Ask your provider about this.

You may get infections more easily when you are taking this medicine. Stay away from people with chickenpox or measles. If you are exposed to either of these viruses, contact your healthcare provider right away. Also, do not have any vaccines without getting your healthcare provider's approval first.

When taken in high doses for 4 weeks or more, it is possible that this medicine may slightly limit growth in children or increase your risk of osteoporosis. Talk to your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry an ID card or medical ID bracelet saying that you are taking this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Seizures; unexplained bruising or bleeding; black or tarry bowel movements; severe stomach pain, nausea, or vomiting; dizziness; fainting; fast or irregular heartbeat; chest pain; continuing or severe headaches; bone or joint pains; swelling in your legs or feet, or any unexplained swelling; severe muscle weakness; vision problems; new or worsening depression; unexplained fever, cough, or sore throat; confusion, unusual drowsiness, increased thirst, increased hunger, increased urination, flushing, or fruity-smelling breath.

Other: Increased sweating, mood swings, acne, trouble sleeping, nausea, vomiting, menstrual changes, loss of appetite.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alzheimer’s disease medicines such as donepezil (Aricept), galantamine (Razadyne), and rivastigmine (Exelon)
• Antacids that contain aluminum, calcium, or magnesium, such as Gaviscon, Maalox, Mylanta, Phillips' Chewable Tablets, Rolaids, or TUMS (Take antacids at least 2 hours before or 2 hours after you take this medicine.)
• Antibiotics such as chloramphenicol, ciprofloxacin (Cipro), clarithromycin (Biaxin), levofloxacin (Levaquin), moxifloxacin (Avelox), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antifungal medicines such as amphotericin b (Abelcet, AmBisome, Amphotec), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), fosphenytoin (Cerebyx), phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Any other corticosteroids taken by mouth or inhaled
• Aprepitant (Emend)
• Aspirin and other salicylates
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cancer medicines such as brentuximab (Adcetris), dasatinib (Sprycel), idelalisib (Zydelig), imatinib (Gleevec), mitotane (Lysodren), sorafenib (Nexavar), sunitinib (Sutent), teniposide, and vincristine (Marqibo)
• Cholesterol-lowering medicines such as cholestyramine (Prevalite) and colestipol (Colestid)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Diabetes medicines such as acarbose (Precose), alogliptin/metformin (Kazano), canagliflozin (Invokana), canagliflozin/metformin (Invokamet), dapagliflozin (Farxiga), dapagliflozin/metformin (Xigduo), dulaglutide (Trulicity), empagliflozin (Jardiance), exenatide (Bydureon, Byetta), glipizide (Glucotrol), glyburide (Glynase), insulin, linagliptin (Tradjenta), linagliptin/metformin (Jentadueto), metformin (Fortamet, Glucophage, Riomet), nateglinide (Starlix), pioglitazone (Actos), pramlintide (Symlin), repaglinide (Prandin), saxagliptin (Onglyza), sitagliptin (Januvia), and sitagliptin/metformin (Janumet)
• Digoxin (Lanoxin)
• Diuretics (water pills) such as bumetanide, ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide), and spironolactone (Aldactone)
• Echinacea
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings, and estrogen hormones such as Cenestin, Estinyl, Estrace, Estraderm, Estratab, FemPatch, Premarin, and Vivelle
• Nefazodone
• Nicardipine (Cardene)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Oxymetholone (Anadrol-50)
• Vaccines
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.